Abstract Number: PB0637
Meeting: ISTH 2020 Congress
Background: Fibrinogen assay is one pillar of routine coagulation screening and clotting Clauss method is established as the gold standard, especially for patients with low fibrinogen levels (Miesbach W, Thromb Res 2010).
With the trend of laboratory services consolidation both through private organizations or within groups of public hospitals, and keeping in mind the need of ensuring patient medical care continuity, consistency of tests results whatever the analyzer is compulsory. Quality management plans within those pathology laboratories networks help verifying this consistency over time. Yet, manufacturers also have their responsibility in showing this agreement by design.
Aims: The objective of the study was to establish correlation and agreement of fibrinogen levels as measured with STA®-Liquid Fib on different Stago analyzers.
Methods: 65 frozen patients plasma samples, spread over the fibrinogen measuring range, were tested on STA® Satellite®, STA® Compact® Max and STA®-R Max analyzers, using the precalibrated STA®-Liquid Fib assay (Stago, France).
Each sample was tested on the 3 instruments in parallel and the whole set of samples was tested over 5 days to avoid any bias due to a single run.
Results: Linear regression was performed to evaluate correlations. Slope, intercept and Pearson correlation coefficients of those regressions are displayed in the table.
|Analyzers comparison||Linear regression equation y = ax + b||Pearson correlation coefficient|
|STA®-Liquid Fib (g/L)||Slope (a)||Intercept (b)||(r)|
|STA® Compact® Max vs STA®-R Max||0.9573||0.1836||0.9894|
|STA® Satellite® vs STA®-R Max||1.0095||-0.0136||0.9982|
|STA® Satellite® vs STA® Compact® Max||1.0306||-0.1089||0.9860|
[Summary of method comparisons of fibrinogen levels with STA®-Liquid Fib on 3 different types of Stago instruments.]
General agreement was confirmed through Bland and Altman analysis, with an overall mean bias lower than 0.03g/L for all comparisons.
Conclusions: Results confirm the high consistency of fibrinogen level assessment with STA®-Liquid Fib across Stago analyzers: As standardization of fibrinogen results is crucial for accreditation purposes, these good results also preclude an easy method validation process.
Available under liquid format and precalibrated for all Stago analyzers, STA®-Liquid Fib is a flexible solution that can be used advantageously by any laboratory performing fibrinogen level determination with Clauss method while ensuring consistency of patients results within pathology networks.
To cite this abstract in AMA style:Baudier J-, Chaillet L, Genty V, Carlo A, Langlet S. Comparison of Different Stago Instruments for Fibrinogen Level Assessment with STA-liquid Fib [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/comparison-of-different-stago-instruments-for-fibrinogen-level-assessment-with-sta-liquid-fib/. Accessed September 29, 2023.
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